Pivotal Clinical Studies

Pivotal Phase III ZINFORO^® (ceftaroline fosamil) CAP studies
 

The efficacy and tolerability of ZINFORO^® (ceftaroline fosamil) monotherapy have been consistently demonstrated in 6 large, double-blind, Phase III, randomised controlled clinical trials: 3 involving adult patients with cSSTI and 3 involving patients with CAP.^1-4

Primary end point outcomes¹

Clinical cure rates: FOCUS 1 and FOCUS 2
ZINFORO^® (ceftaroline fosamil) 600 mg q12h demonstrated comparable efficacy versus ceftriaxone
1 g q24h in terms of clinical cure rates.
 

Primary end point outcomes²

Clinical cure rates: Asia CAP
ZINFORO^® (ceftaroline fosamil) 600 mg q12h demonstrated superior efficacy versus ceftriaxone 2 g q24h in terms of clinical cure rates.

​​​​​​​Non-inferiority was defined as a lower limit of the 95% CI ≥–10% for the between-group difference. If this was achieved, the protocol stated that superiority would be concluded if the lower limit of the 95% CI ≥0%.² The safety profile of ZINFORO^® (ceftaroline fosamil) was similar to that observed in the pooled Phase III CAP and cSSTI studies.²

​​​​​​​CAP, community-acquired pneumonia; CE, clinically evaluable; CI, confidence interval; cSSTI, complicated skin and soft tissue infection; EOT, end of treatment; FOCUS, ceFtarOline Community-acquired pneUmonia trial vS ceftriaxone in hospitalized patients; ITT, intent-to-treat; IV, intravenous; LFU, late follow-up; ME, microbiologically evaluable; MITT, modified intent-to-treat; MITTE, modified intent-to-treat efficacy; mMITT, microbiologically modified intent-to-treat; PORT, Pneumonia Patient Outcomes Research Team; q12h, every 12 hours; q24h, every 24 hourly TOC, test-of-cure.
​​​​​​​

References: